Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0038104044
Study information
Scientific title
Acronym
Study hypothesis
Does nefazodone improve sleep in insomnia?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Mental and Behavioural Disorders: Insomnia
Intervention
1. Nefazodone
2. Placebo
This is a double blind placebo-controlled crossover study to look at the effects of nefazodone on sleep in insomnia. Patients will be given a two week washout from any psychotropic medication and then randomised to take either 100 mg of nefazodone or placebo for 2 weeks with a 2 week washout, then cross over to the treatment. At the end of the each 2 weeks their overnight sleep will be measured at home by polysomnography and they will be asked to fill in questionnaires about their sleep. Objective and subjective sleep measures will be compared in subject between the two treatment periods.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Objective Total Sleep Time
2. Subjective Sleep Quality
Secondary outcome measures
All other measures of objective and subjective sleep
Overall trial start date
01/10/2001
Overall trial end date
30/09/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients aged 18 to 65 meeting criteria for insomnia (International Classification of Sleep Disorders) and without: use of other psychotropic drugs, allergy to nefazodone, current or past severe mental illness or substance abuse, current depressive illness.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2001
Recruitment end date
30/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cottham House
Bristol
BS16 1JB
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Avon and Wiltshire Mental Health Partnership NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21699717
Publication citations
-
Protocol
French DP, Williams SL, Michie S, Taylor C, Szczepura A, Stallard N, Dale J, A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: study protocol., BMC Fam Pract, 2011, 12, 56, doi: 10.1186/1471-2296-12-56.